A Comparison of Ureteroscopic Treatment of Nephrolithiasis With and Without Moses Technology
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|ClinicalTrials.gov Identifier: NCT04505956|
Recruitment Status : Recruiting
First Posted : August 10, 2020
Last Update Posted : February 17, 2021
|Condition or disease||Intervention/treatment||Phase|
|Nephrolithiasis||Device: Holmium laser lithotripsy with Moses Technology Device: Holmium laser lithotripsy without Moses Technology||Not Applicable|
There is ongoing debate on the optimal means of laser stone fragmentation, and Moses technology is the latest advancement to raise questions regarding clinical utility. Initial preclinical studies demonstrated significantly reduced stone retropulsion and higher stone ablation volume with Moses technology, leading to the conclusion that the system allows more efficient laser lithotripsy. Human studies also showed that laser lithotripsy with Moses technology utilized laser energy in less time for stone fragmentation: 10.0 (2.6-15.0) min without vs 6.0 (2.8-13.0) min with Moses technology.
Others have evaluated the cost effectiveness of Moses technology in their own cohort of 40 patients who underwent standard laser lithotripsy by comparing a 35% projected decrease in procedure time against the cost of the Moses laser fiber and machine. Mean stone size was 10.2 mm in this group of patients, and mean lasing time was 3.0 minutes. While a significant positive association was seen between stone size and laser time, cost analysis failed to show a benefit in using Moses technology across sizes.
To date, there are limited clinical data obtained through rigorous study methodology. In addition, knowledge gaps remain regarding the effect of Moses technology on other clinically meaningful outcomes such as stone-free rate. Therefore, the investigators propose a multi-center, prospective, randomized, double blind clinical trial to further assess the effect of Moses technology for lithotripsy. The investigators aim to study a broader range of outcomes which will be facilitated by being the largest study to date. The investigators also aim to study novel outcomes such as grading retropulsion and visibility by independent blinded review as well as effects of Moses technology on independently reducing surgeon burnout. Indeed, a randomized, double blind clinical trial evaluating Moses technology in 66 patients undergoing ureteroscopy was presented as a 2018 European Association of Urology abstract. While this single center study demonstrated safety and reduced fragmentation time as well as procedure time using Moses technology, it did not show a significant difference in stone-free rates. This study is also yet to be published as a manuscript.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Prospective Randomized Double Blind Clinical Trial to Compare Holmium Laser Lithotripsy With and Without Moses Laser Technology for the Ureteroscopic Treatment of Nephrolithiasis|
|Actual Study Start Date :||January 13, 2021|
|Estimated Primary Completion Date :||December 15, 2021|
|Estimated Study Completion Date :||January 31, 2022|
Experimental: Moses Laser Lithotripsy
Patients will have flexible URS performed in standard fashion, without deviation from the standard of care. Laser settings will be at the surgeons' discretion but will be within the range identified as standard for dusting technique using Moses laser technology.
Device: Holmium laser lithotripsy with Moses Technology
Holmium laser energy will be delivered for the ureteroscopic fragmenting of kidney stones. Energy will be generated by the commercial available, FDA approved Lumenis PulseTM P120H laser system and Moses laser fiber. Renal stones will be fragmented using a dusting technique. Moses laser settings will be turned on.
Other Name: Moses Laser Lithotripsy
Active Comparator: Standard Laser Lithotripsy
Patients will have flexible URS performed in standard fashion, without deviation from the standard of care. Laser settings will be at the surgeons' discretion but will be within the range identified as standard for dusting technique (between 0.2-0.5 J and 40-80 Hz). The short pulse setting will be utilized for non-Moses settings.
Device: Holmium laser lithotripsy without Moses Technology
Holmium laser energy will be delivered for the ureteroscopic fragmenting of kidney stones. Energy will be generated by the commercial available, FDA approved Lumenis PulseTM P120H laser system and Moses laser fiber. Renal stones will be fragmented using a dusting technique. Moses laser settings will be turned off.
Other Name: Standard Laser Lithotripsy
- Operative Time [ Time Frame: Beginning to end of procedure time ]Total operative times between Moses holmium laser lithotripsy and non-Moses holmium laser lithotripsy in the ureteroscopic treatment of renal stones using a dusting technique
- Stone retropulsion [ Time Frame: First 20 seconds of laser lithotripsy ]Stone movement during laser lithotripsy will be recorded on video and graded on a Likert scale by blinded reviewers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04505956
|Contact: Naren Nimmagadda, MD||(615) firstname.lastname@example.org|
|United States, California|
|University of California San Diego||Recruiting|
|San Diego, California, United States, 92103|
|Contact: Seth Bechis, MD|
|United States, New York|
|New York, New York, United States, 10032|
|Contact: Ojas Shah, MD|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Michael Lipkin, MD|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Sriharan Sivalingam, MD|
|United States, Tennessee|
|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Nicole Miller, MD|
|Contact: Naren Nimmagadda, MD|
|Study Director:||Naren Nimmagadda, MD||Vanderbilt University Medical Center|